Trial Outcomes & Findings for Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate) (NCT NCT00961116)
NCT ID: NCT00961116
Last Updated: 2009-11-03
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Results posted on
2009-11-03
Participant Flow
Fifty-four (54) non-obese, non-smoking, healthy adult volunteers, consisting of members of the community-at-large, were enrolled.
Participant milestones
| Measure |
Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast.
|
Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, after an overnight fast.
|
|---|---|---|
|
First Intervention
STARTED
|
27
|
27
|
|
First Intervention
COMPLETED
|
27
|
27
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
27
|
27
|
|
Washout Period of 7 Days
COMPLETED
|
25
|
24
|
|
Washout Period of 7 Days
NOT COMPLETED
|
2
|
3
|
|
Second Intervention
STARTED
|
25
|
24
|
|
Second Intervention
COMPLETED
|
25
|
24
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast.
|
Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, after an overnight fast.
|
|---|---|---|
|
Washout Period of 7 Days
Adverse Event
|
1
|
1
|
|
Washout Period of 7 Days
Withdrawal by Subject
|
1
|
1
|
|
Washout Period of 7 Days
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
Baseline characteristics by cohort
| Measure |
Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets
n=54 Participants
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg following an overnight fast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
23.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.Population: Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Fenofibric Acid 105 mg Tablets
n=49 Participants
Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
|
Fenofibrate 145 mg Tablets
n=49 Participants
Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
12,344.00 ng/mL
Standard Deviation 3,032.94
|
10,940.05 ng/mL
Standard Deviation 2,576.52
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.Population: Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Fenofibric Acid 105 mg Tablets
n=49 Participants
Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
|
Fenofibrate 145 mg Tablets
n=49 Participants
Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
159,866.23 ng-hr/mL
Standard Deviation 63,847.90
|
170,727.10 ng-hr/mL
Standard Deviation 66,257.75
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.Population: Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Fenofibric Acid 105 mg Tablets
n=49 Participants
Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
|
Fenofibrate 145 mg Tablets
n=49 Participants
Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
|
176,816.78 ng-hr/mL
Standard Deviation 75,989.60
|
188,331.49 ng-hr/mL
Standard Deviation 78,194.95
|
Adverse Events
Fenofibric Acid 105 mg Tablets
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Fenofibrate 145 mg Tablets
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fenofibric Acid 105 mg Tablets
Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours.
|
Fenofibrate 145 mg Tablets
Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/35
|
3.0%
1/33 • Number of events 1
|
Other adverse events
| Measure |
Fenofibric Acid 105 mg Tablets
Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours.
|
Fenofibrate 145 mg Tablets
Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
|
Gastrointestinal disorders
Stomach Discomfort
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
General disorders
Feeling cold
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/51
|
3.8%
2/52 • Number of events 2
|
|
Infections and infestations
Skin bacterial infection
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
|
Investigations
Blood human chorionic gonadotropin increased
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
Nervous system disorders
Headache
|
7.8%
4/51 • Number of events 4
|
9.6%
5/52 • Number of events 5
|
|
Nervous system disorders
Ulnar nerve palsy
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmennorrhea
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.0%
1/51 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60